NEWCOMER SUPPLY INC

FDA Device Registration & Listing · Waunakee, WI, US · Registration 3008174888

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008174888
FEI Number
3008174888
Entity Name
NEWCOMER SUPPLY INC
City/State/Country
Waunakee, WI, US
Establishment Address
1020 Prairie View Ct, Waunakee, WI 53597, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Newcomer Supply Inc (Owner Number: 10043462)
Owner / Operator Contact Address
1020 PRAIRIE VIEW CT, Waunakee, WI 53597, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Schiff Reagent, McManus Orange G Stain 1%, Aqueous Wright Stain, Modified Thiazine Stain Xanthene Stain Wright Stain Wright Stain, Buffered Wright Stain Buffer, pH 6.8 Isotonic Buffered Saline (PBS) Phosphotungstic Acid 5%, Aqueous Acetic Acid 0.5%, Aqueous Gallego Solution Phosphotungstic – Acetic Acid, Aqueous Acetic Acid, Glacial, ACS Acetic Acid 10%, Aqueous Phosphotungstic Acid 2%, Alcoholic Acetic Acid 1%, Aqueous Acetic Acid 3%, Aqueous Methylene Blue Stain 0.5%, Aqueous Methylene Blue Stain 1.4%, Alcoholic Methylene Blue, Powder Newly Blue Stain Set New Methylene Blue N Stain, Aqueous Methylene Blue Stain 0.14%, Alcoholic Formalin 10%, in Saline Formalin Vial 10%, Phosphate Buffered Hollande Fixative Formalin 23%, Phosphate Buffered Formalin Concentrate Form-C (Buffered) AZF Fixative Davidson Fixative Carson Mod. Millonig Formalin Vials Formalin 10%, Phosphate Buffered AZF Fixative Vial Formalin, Alcoholic, 20/80 Zinc Formalin Fixative Fomalin, Alcoholic, 10/90 Millonig Formalin Carson Modified Millonig Formalin Formalin 10%, Aqueous Papanicolaou Stain, EA-50, Fast Green Papanicolaou Stain, EA-50, Light Green Papanicolaou Stain, OG-6 Papanicolaou Stain, EA-65, Fast Green Eosin-Phloxine Stain Set Zamboni Fixative Formaldehyde 37-40%, ACS Hyaluronidase Buffer Hematoxylin Stain Set, Weigert Iron Van Gieson Stain Decalcifying Solution, EDTA/Sucrose Decalcifying Solution, Formic Acid 5%, Aqueous Decalcification End Point Set Decalcifying Solution, Formic/Citrate Formic Acid 96% ACS Decalcifying Solution, HCL/EDTA Decalcifying Solution, Formic Acid/Formalin Light Green SF Yellowish Stain 1%, Aqueous Trichrome Stain, Gomori One-Step, Light Green Light Green SF Yellowish Stain 0.1%, Aqueous Light Green SF Yellowish Stain 0.2%, Aqueous Light Green SF Yellowish Stain 02%, Aqueous Light Green SF Yellowish Stain 2%, Aqueous Acid Fuchsin Stain, Aqueous Oil Red O Stain, Propylene Glycol Oil Red O, Powder Oil Red O Stain, Isopropanol Fat, Oil Red O, Propylene Glycol Stain Kit Periodic Acid 0.5%, Aqueous Periodic Acid 1%, Aqueous Hematoxylin Stain, Harris Modified Methyl Green Stain 2%, Aqueous Crystal Violet-Oxalate Stain, Alcoholic Crystal Violet Stain, Lieb, Alcoholic Crystal Violet, Powder Crystal Violet Stain 1%, Aqueous, Brown-Hopps Aniline Blue Stain, Aqueous Aniline Blue, Powder Basic Fuchsin Stain 0.25%, Aqueous Basic Fuchsin, Powder Basic Fuchsin Stain 0.5%, Aqueous Metanil Yellow Stain, Aqueous Auramine O, Powder Jenner Stock Stain Eosin Y Stain 0.5%, Aqueous NaCl Eosin Y, Powder Eosin Y – Phloxine B Working Solution Eosin Y Stock Stain 1%, Alcoholic Eosin Y Stock Stain 1%, Aqueous Eosin Y Working Solution Eosin Y 1%, Isopropyl Alcohol Eosin-Phloxine Stain Set Zenker Fixative, Modified, Zinc Chloride B-5 Fixative Modified, Zinc Chloride Biebrich Scarlet-Acid Fuchsin Stain, Elastic-Trichrome, Aqueous Biebrich Scarlet-Acid Fuchsin Stain, Aqueous Sudan Black B Stain, Propylene Glycol Fast Green Stain 2.5%, Aqueous Trichrome Stain, Gomori One-Step, Fast Green Lithium Carbonate 0.5%, Aqueous Trichrome Stain, Wheatley Modified Potassium Permanganate 0.25%, Aqueous Lithium Carbonate, Saturated Aqueous Sulfuric Acid 1%, Aqueous Chromic Acid 5%, Aqueous Chromic Acid 10%, Aqueous Potassium Permanganate 1%, Aqueous Safranin O Stain 1%, Aqueous Safranin O, Powder Safranin O Stain 0.25%, Aqueous Paraformaldehyde 10%, Buffered Paraformaldehyde 4%, Buffered, Vial Hydrochloric Acid 20%, Aqueous Phosphate Buffered Saline 01M, pH 7.2 Phosphate Buffered Saline 0.1M, pH 7.4 Phosphate Buffered Saline 01M, pH 7.4 Fast Red Enhancer Nuclear Fast Red Stain, Kernechtrot Sudan III Stain, Saturated Alcoholic Paraffin Dispenser XH-4002 Hematoxylin 3%, Alcoholic Hematoxylin Stain, Gill Hematoxylin, Powder Hematoxylin 10%, Alcoholic STAT Aqua Hematoxylin (Permanent) Hematoxylin 5%, Alcoholic Aniline Blue Stain, Aqueous Trichrome Stain, Gomori One-Step, Aniline Blue Blastomyces sp. Epithelial Membrane Antigen (EMA) Fungus, GMS, Aspergillus sp Artificial Neuron-Specific Enolase (NSE) Toxoplasma sp Animal Alcian Blue/PAS Trichrome, Multi-Tissue Cytokeratin 20 (CK20) Kappa Acid Fast Bacteria (AFB), Animal Spirochete, Animal Carcinoembryonic Antigen (CEA) Chromogranin A Argentaffin Elastic, Aorta Cytomegalovirus, (CMV) CD45, Leucocyte Common Antigen (LCA) Amyloid, Animal Cryptococcus sp. Cytokeratin, HMW Lambda Fungus, PAS, Aspergillus sp Artificial Leptospira sp Animal Cat Scratch Bartonella Sp Artificial Colloidal Iron Giemsa Urates HMB-45 S-100 Gram, Multi-Tissue, Artificial Actin, Smooth Muscle Spirochete Animal Melanin CD23 Fungus, GMS, Candida sp Artificial Legionella sp. CD8 p63 Wilms' Tumor (WT1) Mast Cell CD15 Fite, Nocardia sp Artificial Mismatch Repair (MMR) Positive Alcian Blue pH 2.5, Multi-Tissue Trichrome, Kidney Cytokeratin 7 (CK7) Blastomyces sp Animal Glial Fibrillary Acidic Protein (GFAP) CK5/14 + p63 + P504S, Multi-Tissue Movat-Russell Pentachrome CD31, PECAM-1 Desmin Calcium Fungus, PAS, Candida sp Artificial Hepatitis B Core Antigen (HBcAG) CK5/14 + p63 + P504S Alcian Blue pH 2.5, Goblet Cell Mucin Mucicarmine CD30 DOG1 Cat Scratch Bartonella sp Artificial Fungus, GMS, Multi-Tissue, Artificial Hepatitis B Surface Antigen (HBsAG) Prostate Specific Antigen (PSA) Basement Membrane CD34 Helicobacter Sp Artificial Argyrophil Elastic, Skin Melan-A (MART-1) Alcian Blue pH 2.5, Barrett's Esophagus Copper, Animal Trichrome, Uterus Cytokeratin AE1/AE3 Ki-67 Helicobacter sp Animal CD20, B-Cell Spirochete Treponema Sp Artificial Alcian Blue pH 2.5, Umbilical Cord Trichrome, Liver Cytokeratin 5/6 (CK5/6) Bielschowsky CD56 Helicobacter Sp Animal Bile E-cadherin Mast Cell, Animal CD117, c-Kit Spirochete, Artificial Calretinin CDX2 Hematoxylin and Eosin (H&E) Phosphotungstic Acid Hematoxylin (PTAH) CA-125 CD68 Thyroid Transcription Factor (TTF-1) Luxol Fast Blue (LFB) CD10 Helicobacter sp Artificial Periodic Acid Schiff (PAS) Glycogen BCL2 Synaptophysin Helicobacter sp. Pneumocystis sp Animal Alpha-Fetoprotein (AFP) CD3, T-Cell Fungus, GMS Iron, Animal Collodial Iron, Multi-Tissue p53 Gram, Gram Positive & Gram Negative Bacteria, Artificial Vimentin Actin, Muscle Specific SOX-10 Histoplasma sp Animal Reticulum Calponin CD138 Fungus, GMS, Aspergillus sp Animal Iron p40 Uro-2™ (CK20 + p53), Multi-Tissue Grocott Methenamine Silver Set, GMS Methenamine 3%, Aqueous Methenamine Borate Carbol Fuchsin Stain, Ziehl-Neelsen Carbol Fuchsin Stain, Kinyoun Toluidine Blue Stock Stain 1%, Aqueous Toluidine Blue Stain 0.1%, Aqueous Phosphotungstic Acid 4%, Alcoholic Phosphotungstic Acid Hematoxylin (PTAH) Stain Phosphomolybdic – Phosphotungstic Acid, Aqueous Gold Chloride 0.25%, Aqueous Gold Chloride 1%, Aqueous Gold Chloride 0.1%, Aqueous Gold Chloride 0.2%, Aqueous Giemsa, Powder Giemsa Stock Stain, Wolbach Giemsa Stock Stain Giemsa Stock Stain, Romanowsky Luxol Fast Blue (LFB) Stain Set Michel's Transport Medium Zinc Formalin Fixative Michel's Transport Medium Vial Michel's Wash Solution Zinc Formalin Sensitizer Potassium Ferricyanide 1%, Aqueous Ferric Chloride 2%, Aqueous Uranyl Nitrate 1%, Aqueous Victoria Blue Stain, Alcoholic Gum Mastic 2.5%, Alcoholic Potassium Permanganate 1%, Aqueous Ferric Chloride 29%, Aqueous Stock Hydroquinone, Powder Ferric Ammonium Sulfate 2.5%, Aqueous Potassium Permanganate 0.25%, Aqueous Tartrazine Stain 1.5%, Aqueous Tartrazine Stain 0.25%, Acetic Aqueous Saffron, Powder Ferric Chloride 1%, Aqueous Rhodanine Stock Stain 0.2%, Alcoholic Ferric Chloride 10%, Aqueous Acetone-Alcohol 1:1 Slide Brite Xylene, ACS Acetone-Xylene 1:1 Xylene, Histology Grade Acetone, ACS Clear Choice Xylene/Peanut Oil, 2:1 Alcohol, Isopropyl ACS, 100% Egg Albumin Adhesive Iodine, Gram, Aqueous Acidulated Water pH 4 – 4.1 Hydrogen Peroxide 30%, Aqueous Hematoxylin Stain Set, Weigert Iron Mucicarmine Stock Stain, Mayer Mayer Hematoxylin Stain Solution, Mayer Modified Hematoxylin Stain, Mayer Modified Nigrosin Stain 10%, Aqueous Nigrosin, Powder, CI 50420

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HZT Reagent, Schiff Hematology Class 1 864.1850 2024-10-14
HZH Orange G Hematology Class 1 864.1850 2025-02-05
IAF Wright'S Stain Hematology Class 1 864.1850 2024-10-14
JCE Solution, Isotonic Pathology Class 1 864.4010 2024-10-16
IGF Solution, Formalin-Alcohol-Acetic Acid Pathology Class 1 864.4010 2024-10-22
KFC Methylene Blue, Tissue Stain Hematology Class 1 864.1850 2024-10-15
IFP Formalin, Neutral Buffered Pathology Class 1 864.4010 2024-10-16
HZJ Stain, Papanicolau Hematology Class 1 864.1850 2024-10-11
HZL Phloxine B Hematology Class 1 864.1850 2024-10-11
IGG Formaldehyde (Formalin, Formol) Pathology Class 1 864.4010 2024-10-16
IBD Hyaluronidase Pathology Class 1 864.4400 2024-10-15
HYO Hematoxylin Weigert'S Hematology Class 1 864.1850 2024-10-11
IAC Van Gieson'S Stain Hematology Class 1 864.1850 2024-10-14
KDX Solution, Decalcifier, Acid Containing Pathology Class 1 864.4010 2024-10-17
HYS Light Green Hematology Class 1 864.1850 2024-10-11
IDF Acid, Fuchsin Hematology Class 1 864.1850 2025-02-05
HZG Oil Red O Hematology Class 1 864.1850 2024-10-11
KKS Acid, Periodic Hematology Class 1 864.1850 2024-10-15
HYK Hematoxylin Harris'S Hematology Class 1 864.1850 2024-12-19
HZA Methyl Green Hematology Class 1 864.1850 2024-10-11
ICF Crystal Violet For Histology Hematology Class 1 864.1850 2024-10-14
ICX Aniline Hematology Class 1 864.1850 2024-10-14
KKW Basic Fuchsin Hematology Class 1 864.1850 2024-10-15
HYY Metanil Yellow Hematology Class 1 864.1850 2024-10-11
KJK Auramine O Hematology Class 1 864.1850 2024-10-15
KJX Jenner Stain Hematology Class 1 864.1850 2024-10-15
HYB Eosin Y Hematology Class 1 864.1850 2024-10-11
IFH Solution, Zenker'S Pathology Class 1 864.4010 2024-10-16
LDX Fixative, Metallic Containing Pathology Class 1 864.4010 2024-12-19
ICN Biebrich Scarlet Hematology Class 1 864.1850 2024-10-14
HZZ Sudan Black B Hematology Class 1 864.1850 2024-10-14
HYC Fast Green Hematology Class 1 864.1850 2024-10-11
JTS Stains, Microbiologic Hematology Class 1 864.1850 2024-10-22
HZS Safranin Hematology Class 1 864.1850 2024-10-14
KEF Paraformaldehyde Pathology Class 1 864.4010 2024-12-19
LDW Fixative, Acid Containing Pathology Class 1 864.4010 2024-11-18
KIP Formulations, Balanced Salt Solutions Hematology Class 1 864.2875 2024-12-19
HYD Fast Red Salt B Hematology Class 1 864.1850 2024-10-11
HZF Nuclear Fast Red Hematology Class 1 864.1850 2024-10-11
KKJ Sudan Iii Hematology Class 1 864.1850 2024-10-15
IDW Dispensers, Paraffin Pathology Class 1 864.3010 2024-10-15
HYJ Hematoxylin Hematology Class 1 864.1850 2024-10-11
KFD Aniline Blue Hematology Class 1 864.1850 2024-10-15
LJG Quality Control Slides Microbiology Class 1 866.2660 2013-02-19
HYZ Methenamine Silver Hematology Class 1 864.1850 2024-10-11
ICL Carbol Fuchsin Hematology Class 1 864.1850 2024-10-14
IAB Toluidine Blue Hematology Class 1 864.1850 2024-10-14
HZM Hematoxylin, Acid, Phosphotungstic Hematology Class 1 864.1850 2024-10-11
HYH Gold Chloride Hematology Class 1 864.1850 2024-10-11
HYF Giemsa Stain Hematology Class 1 864.1850 2024-10-22
HYT Luxol Fast Blue Hematology Class 1 864.1850 2024-10-11
LDY Fixative, Formalin-Containing Pathology Class 1 864.4010 2024-12-19
LEE Stains, Dye Solution Hematology Class 1 864.1850 2024-10-22
KEM Agent, Clearing Pathology Class 1 864.4010 2024-10-18
KEL Adhesive, Albumin-Based Pathology Class 1 864.4010 2024-10-17
HYI Iodine, Grams Hematology Class 1 864.1850 2024-10-11
NJT Immunohistochemistry Reagents And Kits Hematology Class 1 864.1860 2024-12-19
IAE Hematoxylin, Iron, Weigert'S Hematology Class 1 864.1850 2024-10-14
HYL Hematoxylin Mayer'S Hematology Class 1 864.1850 2024-10-11
KKD Nigrosin Hematology Class 1 864.1850 2024-10-15

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Newcomer Supply Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K821443 Lerner Laboratories, Inc. FORMICAL 1982-06-02
K843684 Sigma Chemical Co. SIGMA SUDAN BLACK REAGENT 380-1 1984-10-31

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0025-05 Becton Dickinson & Co. 1
Difco (TM) BBL (TM) Gram Crystal Violet, 250 mL bottles in packs of four, catalog # 212525 and 3.8 L bottles, catalog # 212526, staining reagent.
Z-0012-2015 Richard-Allan Scientific Company 1
Protocol 10% NBF Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
Z-0013-2015 Richard-Allan Scientific Company 1
Richard-Allan Scientific Specimen Transportation System. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
Z-0014-2015 Richard-Allan Scientific Company 1
Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
Z-0015-2015 Richard-Allan Scientific Company 1
Richard-Allan Scientific Bio-Tite Specimen Containers. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008174888. Last updated year: 2026. Please use registration number 3008174888 when referencing this establishment in official correspondence.
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